Method of Treating Deep Vein Thrombosis

ABSTRACT

A method of treating deep vein thrombosis in a limb of user includes applying a deep vein thrombosis treatment sleeve onto the limb of the user so that portions of the user&#39;s limb extend from opposite open ends of the deep vein thrombosis treatment sleeve; allowing the deep vein thrombosis treatment sleeve to conform to the limb and adhere to the limb over the area of the user&#39;s limb where the deep vein thrombosis resides through negligible compression suction adhesion; heating up the deep vein thrombosis treatment sleeve with a user&#39;s body heat so that the user barely notices the deep vein thrombosis treatment sleeve on the user&#39;s limb; and treating the deep vein thrombosis with the deep vein thrombosis treatment sleeve on the limb of the user over the area of the user&#39;s limb where the deep vein thrombosis resides. The treatment sleeve may also be used for treating a ligament or muscle injury in a joint of a user.

FIELD OF THE INVENTION

The present invention relates, in general, to therapeutic medicaldevices and methods, and, in particular, to devices and methods fortreating deep vein thrombosis.

BACKGROUND OF THE INVENTION

Deep vein thrombosis (DVT) and pulmonary embolism (PE) constitute majorhealth problems in the United States. It has been estimated that 300,000to 600,000 hospitalizations a year are attributable to DVT and PEconditions. Venous thromboembolism is also a significant risk insurgical patient populations where preoperative, operative andpostoperative immobilization with concomitant loss of venous pumpfunction causes blood stasis.

The use of prophylactic antithrombotic drugs for preventing DVT areknown to the art. However, the efficacy of prophylactic administrationof anticoagulants and antiplatelet agents has been disputed, and iscertainly not absolute. An alternative approach, attractive because ofits freedom from hemorrhagic side effects, is the use of speciallyfitted compression stockings designed to treat or help prevent bloodclots from developing in deep leg veins. These stockings are availablefrom a medical supply store with a doctor's prescription or over thecounter at some pharmacies. There are generally two types of compressionstockings used for deep leg vein thrombosis. The type recommended willusually be based upon one of two treatment goals: 1) to relieve symptomsassociated with existing deep leg vein thrombosis, especially swellingand pain, and prevent postthrombotic syndrome. This type of stocking mayalso help prevent additional clots from forming, although this is notits primary function. Compression stockings for existing deep leg veinthrombosis are expensive, usually around $150 per pair. 2) To reduce therisk of developing deep leg vein thrombosis in people who are at highrisk. This kind of compression stocking is less expensive than thoseused to help treat existing deep leg vein thrombosis.

Compression stockings are tight at the feet with a gradually looser fiton the leg (graduated compression). They are as thick as two pairs ofregular panty hose and cover the leg from the arch of your foot to justbelow or above your knee. Compression stockings are also available as apanty hose or trouser socks.

Compression stockings have disadvantages. The compressive nature of thestockings make them uncomfortable to wear, especially when worn all day.They are hot and may be difficult to put on, especially for olderadults, overweight people, and people with arthritis. Also, many medicalprofessionals do not believe compression stockings are useful to treatdeep leg vein thrombosis.

SUMMARY OF THE INVENTION

Accordingly, an aspect of the invention involves a deep vein thrombosistreatment sleeve and method of treating deep vein thrombosis in a limbof a user where a deep vein thrombosis treatment sleeve made ofmaterials such as, but not limited to, urethane, polyurethane, orpolyether-based aromatic polyurethane is applied to and maintained inposition on a limb of a user suffering from deep vein thrombosis overthe area where the deep vein thrombosis exists through negligiblecompressive suction adhesion to treat deep vein thrombosis without thediscomfort suffered by compression stocking users.

Another aspect of the invention involves a method of treating deep veinthrombosis in a limb of user. The method includes providing a deep veinthrombosis treatment sleeve having a generally tubular configurationwith at least one open end in use and configured to apply negligiblecompressive engagement to the limb of the user disposed thereon;applying the deep vein thrombosis treatment sleeve onto the limb of theuser over the area of the user's limb where the deep vein thrombosisresides and a portion of the user's limb extends from at least one openend of the deep vein thrombosis treatment sleeve; allowing the deep veinthrombosis treatment sleeve to conform to the limb and adhere to thelimb over the area of the user's limb where the deep vein thrombosisresides through negligible compression suction adhesion; heating up thedeep vein thrombosis treatment sleeve with the body heat of the useruntil the deep vein thrombosis treatment sleeve reaches the bodytemperature of the limb the deep vein thrombosis treatment sleeve isapplied to so that the user barely notices the deep vein thrombosistreatment sleeve on the user's limb; and treating the deep veinthrombosis with the deep vein thrombosis treatment sleeve on the limb ofthe user over the area of the user's limb where the deep vein thrombosisresides.

A further aspect of the invention involves a method of treating aligament or muscle injury in a joint of a user. The method includesproviding a treatment sleeve having a generally tubular configurationwith at least one open end in use and configured to apply negligiblecompressive engagement to the joint of the user disposed thereon;applying the treatment sleeve onto the joint of the user where theligament or muscle injury resides, the joint being at least one of aknee, an ankle, an elbow, and a wrist of the user; allowing thetreatment sleeve to conform to the joint and adhere to the joint overthe area of the ligament or muscle injury through negligible compressionsuction adhesion; heating up the treatment sleeve with the body heat ofthe user until the treatment sleeve reaches the body temperature of thejoint the treatment sleeve is applied to so that the user barely noticesthe treatment sleeve on the user's joint; and treating the ligament ormuscle injury in the joint with the treatment sleeve on the joint of theuser over the area of the user's joint where the ligament or muscleinjury resides.

Further objects and advantages will be apparent to those skilled in theart after a review of the drawings and the detailed description of thepreferred embodiments set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of a treatment sleeve thatmay be used for treating deep vein thrombosis and the associated pain.

FIG. 2 is a perspective view of a leg of a user and illustrates areas ofthe leg where the treatment sleeve may be applied for treating deep veinthrombosis or an injury area and the associated pain.

FIG. 3 is a rear elevational view of an arm of a user and illustratesinjury areas of the arm where the treatment sleeve may be applied fortreating deep vein thrombosis or an injury area and the associated pain.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

With reference to FIG. 1, an embodiment of a treatment sleeve 100 andassociated method for treating deep vein thrombosis and the associatedpain in a user's leg, arm, or pelvis will now be described. Although thetreatment sleeve 100 will initially be described for the treatment ofdeep vein thrombosis, the treatment sleeve 100 may be used to treatother complications such as, but not limited to, sports injuries,ligament sprains or tears, muscle strains or tears, pain areas, carpaltunnel syndrome, joint injuries in the legs and other areas of the body,and other related injuries.

In the embodiment shown, the treatment sleeve 100 has a generallytubular shape, and, more specifically, a generally truncated conicalshape sized and configured to snugly conform to the shape of a lower leg105 (FIG. 2) or an arm 200 (FIG. 3) of a wearer. The treatment sleeve100 has a larger diameter circular open end 110 and a smaller diametercircular open end 120 connected by a generally conical main body portion130 of a uniform elasticity. The treatment sleeve 100 has a thickness Tthat preferably ranges between 1.5 mm -6 mm and a length L thatpreferably ranges from 12 cm (e.g., a narrow band) to the distancebetween the end of a user's foot and the ischium; however, inalternative embodiments, the treatment sleeve 100 has a thickness Tand/or length L outside of this range.

The treatment sleeve 100 is preferably injection molded and made of aresiliently stretchable non-compressive material that naturally adheresto the skin of the wearer with negligible compression on the skin of thewearer. As used herein, “negligible compression” means at bodytemperature the treatment sleeve 100 does not interfere with any bloodflow of the user. The material of the treatment sleeve 100 isadvantageously soft at body temperature, conforms and adheres to theshape of the body part thereunder through non-compressive suctionadhesion to maintain the sleeve in position upon the body part withnegligible compression and without restricting blood flow and shiftingof the treatment sleeve 100 during movement or physical activity.

Exemplary materials that may be used for the treatment sleeve 100 areurethane or polyurethane. In a preferred embodiment, the sleeve 100 ismade of a polyether-based aromatic polyurethane material. The urethaneor polyurethane material has excellent memory which enables the sleeve100 to return to its original shape or the shape of the body parthereunder while applying negligible compressive forces on the user'sskin after stretching. Although the treatment sleeve 100 is described aspreferably being made of polyurethane or urethane, in alternativeembodiments, the treatment sleeve 100 may be made of an elastic siliconeor another material that is elastic, provides negligible compression atbody temperature, and adheres to the skin of the user naturally. Thematerial of the sleeve 100 may be optionally reinforced with a clothreinforcement that does not interfere with the elasticity of the sleeve100.

When the treatment sleeve 100 is applied over a joint (e.g., knee,elbow, wrist, ankle) and is at body temperature, the sleeve 100 does notinterfere with flexion of the joint.

Although the treatment sleeve 100 is shown as having a generally tubularconstruction with two open ends 110, 120, in alternative embodiments,the treatment sleeve 100 may have an open end 110 and a closed end 120(e.g., the closed end may be snug around the user's toes in a footapplication), the treatment sleeve 100 may have an open end 110 and aclosed end 120 with substantially the same size or diameter, or thetreatment sleeve 100 may have other configurations or the treatmentsleeve 100 may be made of a flat piece or sheet of material that iswrapped circumferentially around the user's leg 105 or other body part.For example, in such an embodiment, opposite end portions of the flatpiece of material may include respective hook fasteners and loopfasteners (e.g., Velcro®) to connect the opposite end portions forcircumferential attachment of the treatment sleeve 100 around the user'sleg 105 or other body part.

To treat deep leg vein thrombosis, the treatment sleeve 100 is appliedto the user's leg 105 over the location of the deep leg vein thrombosis.The user's foot is inserted through the larger diameter circular openend 110, fed through the generally conical main body portion 130, andinserted out through the smaller diameter circular open end 120, similarto feeding one's leg through the leg of one's pants when putting onone's pants. The treatment sleeve 100 is then pulled up the user's leg105 to the location of the deep vein thrombosis. It should be noted thatwhen applying the treatment sleeve to the user's leg 105, the treatmentsleeve 100 is elastically stretched. When the treatment sleeve is inposition over the location of the deep vein thrombosis, the memory ofthe elastic treatment sleeve 100 enables the sleeve 100 to conform tothe shape of the user's leg 105. The user's body heats the treatmentsleeve 100 up to the temperature of the user's body in approximately10-15 minutes. Once the treatment sleeve 100 is at body temperature, thetreatment sleeve 100 is advantageously soft, conforming and adhering tothe shape of the user's leg thereunder through non-compressive suctionadhesion to maintain the sleeve 100 in position upon the user's leg withnegligible compression and without restricting blood flow in the leg105. In this position, the treatment sleeve 100 creates a sealedenvironment around the target deep vein thrombosis or pain area withoutan adhesive such as glue and with negligible compression. In thiscondition, the treatment sleeve 100 also takes on the feel of anotherlayer of skin to the user so that the user barely notices or does notnotice the treatment sleeve 100. Application of the treatment sleeve 100causes the pain, swelling, and other symptoms from deep vein thrombosisin the leg 105 to subside. Because of the negligible compression of thetreatment sleeve 100 and skin-like feel that the treatment sleeve 100takes on after the body warms it to body temperature, the treatmentsleeve 100 can be worn for long periods of time without discomfort. Theuser may remove the treatment sleeve 100 from the leg 105 in an oppositemanner to that described above for applying the treatment sleeve 100 tothe leg 105, similar to removing one's pant leg of one's pants whentaking off one's pants. It has been determined that the user continuesnot to feel pain from deep vein thrombosis or the pain is minimized fora period of time after the treatment sleeve 100 is removed from theuser's leg 105. Further, the period of time that the user does not feelpain, swelling or other symptoms from deep vein thrombosis afterremoving the treatment sleeve 100 increases the longer the treatmentsleeve 100 is applied to the user's leg 105.

The treatment sleeve 100 may be applied to one or more of a lower legarea 140, a knee area 150, an upper leg area 160, a bicep area 170, anelbow area 180, and a forearm/wrist area 190 for treating deep veinthrombosis or for treating other complications. Although the treatmentsleeve 100 has been described for the treatment of deep vein thrombosis,the treatment sleeve 100 may be used to treat other complications suchas, but not limited to, sports injuries, ligament sprains or tears,muscle strains or tears, pain areas, carpal tunnel syndrome, and jointinjuries in the legs and other areas of the body. Similar to thatdescribed above for treating deep vein thrombosis, it has beendetermined that the user continues not to feel pain from the sportsinjury, ligament sprain, etc. or the pain is minimized for a period oftime after the treatment sleeve 100 is removed from the user's limb.Further, the period of time that the user does not feel pain or othersymptoms from the sports injury, ligament sprain, etc. after removingthe treatment sleeve 100 increases the longer the treatment sleeve 100is applied to the user's limb.

It will be readily apparent to those skilled in the art that stillfurther changes and modifications in the actual concepts describedherein can readily be made without departing from the spirit and scopeof the invention as defined by the following claims.

1-18. (canceled)
 19. A method of treating a ligament or muscle injury ina joint of a user, comprising: providing a treatment sleeve having agenerally tubular configuration with at least one open end in use andconfigured to apply negligible compressive engagement to the joint ofthe user disposed thereon; applying the treatment sleeve onto the jointof the user where the ligament or muscle injury resides, the joint beingat least one of a knee, an ankle, an elbow, and a wrist of the user;allowing the treatment sleeve to conform to the joint and adhere to thejoint over the area of the ligament or muscle injury through negligiblecompression suction adhesion; heating up the treatment sleeve with thebody heat of the user until the treatment sleeve reaches the bodytemperature of the joint the treatment sleeve is applied to so that theuser barely notices the treatment sleeve on the user's joint; treatingthe ligament or muscle injury in the joint with the treatment sleeve onthe joint of the user over the area of the user's joint where theligament or muscle injury resides.
 20. The method of claim 19, whereinat body temperature the treatment sleeve does not interfere with flexionof the joint.
 21. The method of claim 19, wherein the treatment sleeveis made of urethane.
 22. The method of claim 19, wherein the treatmentsleeve is made of polyurethane.
 23. The method of claim 19, wherein thetreatment sleeve is made of polyether-based aromatic polyurethane. 24.The method of claim 19, wherein the treatment sleeve is made of anelastic silicone material with negligible compression at bodytemperature while adhering naturally to the user's skin.
 25. The methodof claim 19, wherein the treatment sleeve is provided in a flat sheet ofmaterial prior to application onto the joint, and is wrapped around thejoint.
 26. The method of claim 19, wherein the treatment sleeve includesopposite open ends.
 27. The method of claim 26, wherein one of theopposite open ends of the treatment sleeve is larger than the other. 28.The method of claim 26, wherein the opposite open ends are substantiallythe same size.
 29. The method of claim 19, wherein the treatment sleevehas a truncated conical configuration.
 30. The method of claim 19,wherein the treatment sleeve is a band.
 31. The method of claim 19,wherein the treatment sleeve is reinforced with a cloth reinforcement.32. The method of claim 19, further including removing the treatmentsleeve, and symptoms of the ligament or muscle injury in the joint notreturning for a period of time after removing the treatment sleeve. 33.The method of claim 32, wherein the period of time that the symptoms ofthe ligament or muscle injury in the joint do not return after removingthe treatment sleeve increases with increases in the amount of time thatthe treatment sleeve is applied, and the method further includesincreasing the amount of time that the treatment sleeve is applied tothe joint before removing the treatment sleeve to increase the period oftime that the symptoms of the ligament or muscle injury in the joint donot return after removing the treatment sleeve.